Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.

We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study

NCT06350474

Cystic Fibrosis

COMPLETED NA

Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis

NCT01223183

Cystic Fibrosis

COMPLETED PHASE1

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

NCT00117208

Cystic Fibrosis

COMPLETED PHASE2

Dornase Alfa Administered to Patients With COVID-19 (DACOVID)

NCT04387786

COVID-19 Mechanical Ventilation

COMPLETED

The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis

NCT00271310

Cystic Fibrosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atelectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal saline

Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Group Type PLACEBO_COMPARATOR

Normal saline:

Intervention Type DRUG

Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Hypertonic saline

Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Group Type ACTIVE_COMPARATOR

Hypertonic Saline

Intervention Type DRUG

Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Dornase alpha

2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Group Type ACTIVE_COMPARATOR

Dornase alpha

Intervention Type DRUG

2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal saline:

Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Intervention Type DRUG

Hypertonic Saline

Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Intervention Type DRUG

Dornase alpha

2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Normal Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patient on invasive mechanical ventilation
2. New Onset (\<48 hours) lobar or multilobar lung atelectasis based on CXR

Exclusion Criteria

1. Asthma
2. Severe COPD (FEV1\<30%)
3. Pneumothorax or massive pleural effusion, thought to be causing the atelectasis
4. Lobar atelectasis secondary to compressive tumor.
5. Severe hypoxemia (PaO2/FiO2 \< 75)
6. Hemodynamic Instability
7. Cystic fibrosis patients
8. Allergy to DNase
9. Patients on Acetylcysteine
10. Pregnant women

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No